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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # CQV System Lead - Viral Vector Process Equipment - **Company:** Sonitalent LLC - **Location:** Devens, MA, United States - **Experience:** Expert - **Contract:** Temporary contract - **Skills:** IBM Rational ClearCase, Data Integrity, Document Management Systems, Software Requirements Analysis, Iq/oq/pq, Computerised Systems - **Published:** July 11, 2026 - **Apply:** https://www.dice.com/job-detail/a01b3cf1-64fe-4bed-a1af-be0749b5bdac ## About the Role * 10+ years process equipment CQV in biologics/cell therapy/gene therapy * Bioreactors * Chromatography systems * TFF systems * Centrifuges * Mixing systems * Single-use technologies * Strong GMP and validation knowledge. * single-use systems * vendor FAT/SAT leveraging * protocol author/execution * field troubleshooting., * 10+ years process equipment CQV in biologics, cell therapy, gene therapy, viral vector, vaccine, or sterile manufacturing environments. * Hands-on familiarity with single-use bioreactors, wave bioreactors, mixers, ATF, depth filtration, chromatography, UF/DF/TFF, transfer panels, TCUs, process pumps/skids, and filter integrity testing. * Experience reviewing vendor FAT/SAT packages and turning them into leveraged qualification evidence with clear punch-item and deviation handling. * Can author/review protocols and execute in the field, including walkdowns, receipt verification, commissioning checks, IOQ testing, discrepancy documentation, and final report closeout., * ValGenesis execution/routing experience is preferred; candidate must be comfortable with electronic protocol evidence expectations. * Must work closely with engineering, vendors, construction turnover, operations/MS&T, quality, automation/IT as needed, and the senior validation SME. * Hybrid role with onsite presence during FAT/SAT, walkdowns, commissioning, and IOQ execution windows in Devens, MA. ## Description Lead C&Q documentation, vendor leveraging, walkdowns, commissioning readiness, and qualification execution for viral vector drug substance process equipment and related single-use process systems. This role needs a field-capable biologics process equipment validation lead who can own systems through turnover, SAT, commissioning, IOQ, evidence review, discrepancy resolution, and final reports. Project scope to screen against: * Relevant systems include N-2 Wave Bioreactor, N-1 Wave Bioreactors, N Production 500L Bioreactor, ATF 10, harvest pump skid, single-use chromatography skid, single-use UF/DF skid, jacketed single-use mixers, temperature control units, filter integrity testers, tubing welders/sealers, cell culture support equipment, and related utility panels. * Several systems are equipment with computerized systems and require ERES/data integrity/configuration thinking in addition to mechanical/process qualification. * Process equipment deliverables include system requirements, SLIA/SCA where applicable, design review, DQ, QRA, data integrity risk assessment, configuration specification, traceability matrix, FAT/SAT where applicable, commissioning protocol/report, IOQ, QSR, green tag, blue tag, and PQ where applicable. * Some systems are new, modified, existing, or relocated, so the candidate must be able to assess existing evidence and determine the practical path to commissioning/qualification readiness. * Lead CQV activities for upstream and downstream viral vector processing equipment. * Coordinate commissioning with Engineering, Vendors, and Construction teams. * Execute and review commissioning, IQ, OQ, and PQ protocols. * Manage punch lists, deviations, change controls, and CAPAs. * Coordinate equipment startup and operational readiness. * Ensure documentation complies with project and regulatory standards. * Provide daily coordination with Manufacturing and Quality, * Own process equipment document set and execution readiness * lead system walkdowns * author/review QP/IOC/CSR/IOQ/QSR/TM * coordinate vendor protocols * manage discrepancies and punch/deviation handoff. Project deliverables / ownership: * Own assigned process equipment document sets from planning through execution and QSR: QP/DQ/QRA/DI/ERES/configuration/traceability as applicable, commissioning documents, IOQ/PQ, blue tag, and closeout. * Coordinate with equipment suppliers for startup, vendor documentation, SAT execution, turnover documentation, and technical issue resolution. * Manage turnover package review, receipt verification, construction/commissioning evidence, punch items, test exceptions, and deviation handoff. * Feed accurate system status, blockers, and recovery needs into PM/document control trackers. ## Related Videos - [Self-service Quality: QA Without QA](https://www.wearedevelopers.com/videos/100184-self-service-quality-qa-without-qa) - [Exploring 5 Key Applications of AI Abundance with Blockchain Assurance](https://www.wearedevelopers.com/videos/971-exploring-5-key-applications-of-ai-abundance-with-blockchain-assurance) - [Remote Driving on Plant Grounds with State-of-the-Art Cloud Technologies](https://www.wearedevelopers.com/videos/251-remote-driving-on-plant-grounds-with-state-of-the-art-cloud-technologies) - [Startup Presentation: StorX - Future of Cloud Storage](https://www.wearedevelopers.com/videos/1176-startup-presentation-storx-future-of-cloud-storage) - [GenAI Security: Navigating the Unseen Iceberg](https://www.wearedevelopers.com/videos/1744-genai-security-navigating-the-unseen-iceberg) - [How I Built QA from Scratch in a Scaling Startup - no fluff real life story](https://www.wearedevelopers.com/videos/2041-how-i-built-qa-from-scratch-in-a-scaling-startup-no-fluff-real-life-story) ## Related Articles - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Dev Digest 121 - AI goes offline](https://www.wearedevelopers.com/magazine/456-dev-digest-121-ai-goes-offline) - [Highest Paying Tech Companies for Developers](https://www.wearedevelopers.com/magazine/220-highest-paying-tech-companies-for-developers) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development)